| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 |
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| Generic Name | Bone sonometer |
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| Regulation Number | 892.1180 |
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| Applicant | CooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611 |
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| PMA Number | P990016 |
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| Date Received | 03/08/1999 |
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| Decision Date | 01/07/2000 |
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|
Reclassified Date
|
08/18/2008 |
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| Product Code |
MUA |
| Docket Number | 00M-0580 |
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| Notice Date | 02/15/2000 |
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| Advisory Committee |
Radiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid for the diagnosis of osteoporosis and other medical conditions leading to reduced bone density and, ultimately, for the determination of fracture risk. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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|
